Protecting Patient Access to Emergency Medications Act

At a glance

The 1970 federal Controlled Substances Act (CSA) regulates substances with the potential for abuse. However, it didn't address the unique needs of emergency medical services (EMS) when dispensing controlled substances. Learn how the 2017 Protecting Patient Access to Emergency Medications Act (PPAEMA) amended the CSA to standardize EMS controlled substance use and improve emergency patient care.

What led to the PPAEMA

The federal Controlled Substances Act (CSA),A created in 1970, regulates substances with abuse potential. However, it failed to address the unique needs of controlled substance use in emergency medical services (EMS) settings. This resulted in confusion and non-standard practices across states and EMS agencies. The Protecting Patient Access to Emergency Medications Act (PPAEMA), passed in 2017,B adds EMS guidance to the CSA to end the confusion, standardize EMS processes, and improve patient care.

Why EMS needed the PPAEMA

EMS agencies use controlled substances (e.g., opioids, benzodiazepines) for advanced life support patient care,C often under time-critical circumstances. However, until 2017, the CSA lacked guidance regarding administration of controlled substances by EMS agencies and EMS personnel.D The lack of direction led to confusion in the EMS field and caused several states to create their own EMS-related regulations.E

For example, the CSA required anyone making, distributing, administering, or studying controlled substances to register with the United States Drug Enforcement Administration (DEA).F Without guidance specific to EMS, some state governments and EMS agencies interpreted this to mean they could administer controlled substances under the DEA registration of the medical director or hospital overseeing the agency's patient care.G

In addition, some states interpreted the CSA to allow controlled substance administration based on standing orders,H which are written protocols pre-approved by a medical director. This permitted them to administer controlled substances in emergency care without calling a doctor for treatment instruction for each patient.I

In 2011, the DEA asserted that the CSA did not allow for the dispensing of controlled substances under a standing order.J Finally, in 2014 the DEA announced its intention to ban the use of standing orders.K This proposed DEA regulation prompted the introduction of the PPAEMA.L

What the PPAEMA changed about the CSA

The PPAEMA amended the CSA to allow the following EMS practices:

DEA registration for EMS agencies
EMS agencies are allowed to receive their own DEA registration to administer controlled substances. Key factors are:

  • EMS agencies that service multiple states must have a DEA registration for each of those states.
  • Hospital-based EMS agencies may use the hospital's DEA registration and will not need to register with the DEA separately.M

Use of standing orders
EMS agencies are allowed to "administer controlled substances in schedule II, III, IV, or V outside the physical presence of a medical director or authorizing medical professional."N Key factors are:

  • The EMS agency must be authorized to do so by state law.
  • The EMS agency must have a standing orderO or verbal orderP from a medical director or an authorizing medical professional.Q

Storage of controlled substances
EMS agencies may store controlled substances in the agency location registered with the DEA, unregistered locations, and in EMS vehicles used by the agency. The key requirement is that the United States Attorney General must be notified of all unregistered locations at least 30 days before the controlled substances are initially delivered to those locations.R

Restocking EMS vehicles at hospitals
Following an emergency response, EMS agencies may restock their EMS vehicles with controlled substances from a hospital without completing CSA order forms.S

Maintenance of controlled substance records
EMS agencies must follow record requirements stated in the CSA.T The key requirement is that all deliveries of controlled substances must be recorded, and the records must be stored where the controlled substances are received, administered, and discarded.U

EMS agency liability
EMS agencies, under their medical director's supervision, are now liable for ensuring the proper use, maintenance, reporting, and security of controlled substances used by the agency.V

PPAEMA Policy Brief PDF Document‎


Acknowledgments and disclaimers

This document was developed by Emily Sargent, CDC Public Health Law Program intern and JD and MPH candidate at the Indiana University Robert H. McKinney School of Law and the Indiana University Richard M. Fairbanks School of Public Health, with the assistance of Gregory Sunshine, JD, public health analyst, Cherokee Nation Assurance, and Matthew Penn, JD, MLIS, director, Public Health Law Program (PHLP) within the Public Health Infrastructure Center (PHIC).

For further technical assistance with this inventory, please contact PHLP at phlawprogram@cdc.gov. PHLP provides technical assistance and public health law resources to advance the use of law as a public health tool. PHLP cannot provide legal advice on any issue and cannot represent any individual or entity in any matter. PHLP recommends seeking the advice of an attorney or other qualified professional with questions regarding the application of law to a specific circumstance. The findings and conclusions in this summary are those of the author and do not necessarily represent the official views of CDC.

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Content Source:
Public Health Infrastructure Center; Public Health Law
  1. Controlled Substances Act of 1970, Pub.L. 91–513, Title II, 84 Stat. 1242.
  2. Protecting Patient Access to Emergency Medications Act of 2017, Pub.L. 115-83, 131 Stat. 1267 (amending 21 U.S.C. § 823 (2017)).
  3. Opioids are used to manage pain in patients suffering from fractures, trauma, and other painful medical conditions. Benzodiazepines are used to stop potentially life-threatening seizures. See Patient Care, QI and General Safety Comm., National Emergency Medical Services Advisory Council, EMS Utilization of Controlled Substances (2017).
  4. 21 U.S.C. § 823 (2016).
  5. See e.g. D.C. Code § 48-931.02 (2017), S.C. Code Ann. § 44-61-130 (2017), and N.H. Rev. Stat. Ann. § 318-B:10 (2017).
  6. 21 U.S.C § 823 (2016). The current list of controlled substances can be found on the DEA website or in 21 C.F.R. §1308.
  7. See e.g. Or. Admin. R. 333-250-0300 (2017), Fla. Admin. Code r. 64J-1.004 (2017), and N.D. Admin. Code 61-09-01-01 (2017).
  8. See e.g. N.D. Admin. Code 61-09-01-01 (2017), N.Y Comp. Codes R. & Regs. 10, §80.136 (2017), and 172 Neb. Admin. Code Ch. 12 §004.
  9. Strengthening our National Trauma System: Hearing on H.R. 4365 Before the Subcomm. On Health of the H. Comm. on Energy and Commerce, 114th Cong. 1-3 (2016) (Statement of Craig Manifold, D.O., F.A.C.E.P., Chairman, American College of Emergency Physicians).
  10. Letter from John W. Partridge, Chief, Liaison and Policy Section, Office of Diversion Control, Drug Enforcement Admin., U.S. Dep’t of Justice, to Jeremy R. Urekew, Paramedic, Anchorage Fire & Ambulance Dist. (Dec. 19, 2011) (on file with the Nat’l Ass’n of State EMS Officials).
  11. Strengthening our National Trauma System: Hearing on H.R. 4365 Before the Subcomm. On Health of the H. Comm. on Energy and Commerce, 114th Cong. 4 (2016) (Statement of Craig Manifold, D.O., F.A.C.E.P., Chairman, American College of Emergency Physicians).
  12. Protecting Patient Access to Emergency Medications Act, H.R. 304, 115th Cong. (2017).
  13. 21 U.S.C. §§ 823(j)(1)-(3) (2017).
  14. Id. § 823(j)(4); “Medical director” is defined as a physician registered with the DEA to administer controlled substances and who provides medical oversight to an EMS agency. See 21 U.S.C § 823(j)(13)(H) (2017).
  15. “Standing order” is defined as “a written medical protocol in which a medical director determines in advance the medical criteria that must be met before administering controlled substances” to EMS patients. See 21 U.S.C § 823(j)(13)(M) (2017).
  16. “Verbal order” is defined as “an oral directive that is given through any method of communication including by radio or telephone, directly to an emergency medical services professional, to contemporaneously administer a controlled substance to individuals in need of emergency medical services outside the physical presence of the medical director or authorizing medical professional.” See 21 U.S.C § 823(j)(13)(N) (2017).
  17. 21 U.S.C. § 823(j)(4).
  18. Id. § 823(j)(6).
  19. Id. § 823(j)(8).
  20. Record requirements can be found in the Controlled Substances Act of 1970 at 21 U.S.C. §§827(a)-(b).
  21. 21 U.S.C. § 823(j)(9) (2017).
  22. Id. § 823(j)(10).